MAUDE Adverse Event Report: MEDTRONIC VP SHUNT

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/17/2015

Event Type  Injury  

Event Description

My daughter has an adjustable valve on a medtronic vp shunt.The device was placed on (b)(6) 2015 and set at an opening of 2.0.Her symptoms were well managed and minimal for almost 90 days.She has had a recent, significant change in symptoms despite what appears to be a functioning device.Upon investigation it was determined that the device is no longer set to the surgical setting of 2.0.There has been no external exposure to explain the change.She continues to be unstable.They will check the device again monday and make a plan to stabilize her.Either there is an environmental influence on the device that is not known or declared, or the valve is broken and changing itself.

• Brand Name: VP SHUNT
• Type of Device: VP SHUNT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4869366
• MDR Text Key: 5860687
• Report Number: MW5043225
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: RX MEDS: PROZAC; VITAMIN D; OXYCODONE; ZOFRAN; OTC MEDS: MULTIVITAMIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 100